Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434876
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2007-02-12
Brief Title:
The Effects of Quetiapine Seroquel XR on Sleep During Alcohol Abstinence
Sponsor:
Subhajit Chakravorty
Organization:
Corporal Michael J Crescenz VA Medical Center
Study Overview
Official Title:
The Effects of Quetiapine on Sleep During Alcohol Abstinence
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine how efficacy of quetiapine seroquel XR in improving the sleep in recovering alcohol dependent subjects
Detailed Description:
Sober alcohol dependent subjects frequently complain of difficulty falling asleep as well as staying asleep which may eventually lead to relapse Novel antipsychotic medications such as quetiapine have shown some efficacy in treating alcoholism and have also shown some benefit in improving insomnia
The primary aim of this study is to determine the degree to which quetiapine improves sleep in veterans during the early phase of recovery from alcohol dependence The sleep efficiency from an in-lab polysomnogram will be the primary outcome measure Secondary measures of sleep will include the Pittsburgh Sleep Quality Index Insomnia Severity Index and actigraphy Other additional aims will explore for alcohol use and cravings change in psychiatric symptoms using the The Time Line Follow Back measure Penn Alcohol Craving Scale PACS the Patient Health Questionnaire-9 item scale PHQ-9 and the Becks Anxiety Inventory BAI respectively
Twenty four subjects within the first year of sobriety will be enrolled Participants will be undergo an extensive baseline screening procedure After 2 consecutive in-laboratory polysomnograms they will be treated with either Quetiapine XR or matching placebo pills targetting a dose of 400 mg a night The treatment duration will be 8 weeks and during the eight week of treatment they will undergo 2 more nights of in-laboratory polysomnogram All subjects will also receive Medical Management therapy a standardized psychosocial intervention which is medically-based and focusses on alcohol abstinence and medication compliance
The primary aim of this study is to determine the degree to which quetiapine improves sleep in veterans during the early phase of recovery from alcohol dependence The sleep efficiency from an in-lab polysomnogram will be the primary outcome measure Secondary measures of sleep will include the Pittsburgh Sleep Quality Index Insomnia Severity Index and actigraphy Other additional aims will explore for alcohol use and cravings change in psychiatric symptoms using the The Time Line Follow Back measure Penn Alcohol Craving Scale PACS the Patient Health Questionnaire-9 item scale PHQ-9 and the Becks Anxiety Inventory BAI respectively
Twenty four subjects within the first year of sobriety will be enrolled Participants will be undergo an extensive baseline screening procedure After 2 consecutive in-laboratory polysomnograms they will be treated with either Quetiapine XR or matching placebo pills targetting a dose of 400 mg a night The treatment duration will be 8 weeks and during the eight week of treatment they will undergo 2 more nights of in-laboratory polysomnogram All subjects will also receive Medical Management therapy a standardized psychosocial intervention which is medically-based and focusses on alcohol abstinence and medication compliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None